Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biotie Therapies Inc.
Age
30–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Meet Parkinson's Disease (PD) diagnosis consistent with UK PD diagnostic criteria
Meet Hoehn and Yahr PD stage
Good response to levodopa
Stable regimen of anti-parkinson medications
Are able to complete a Parkinson's disease diary
If of childbearing potential(male and female), use an acceptable method of birth control
Able and willing to sign an IRB/IEC approved informed consent
Able and willing to understand study requirements, follow study instructions, attend all visits and undergo all planned tests.
You may not be if
Secondary or atypical Parkinson's
Neurosurgical intervention for Parkinson's disease
Treatment with apomorphine
Treatment with anti-psychotic drugs
Other abnormal findings on physical or neuro exam or history that in the opinion of the investigator would make subject unsuitable for the study or prejudice safety and efficacy evaluation
MMSE less than 26
Subjects with untreated or uncontrolled current episode of major depression
Receipt of any anti-psychotic drugs greater than 1 month in the past 5 years or any exposure in past year (except for quetiapine at doses \<100mg per day)
Women pregnant or lactating
History of hepatitis, cholangitis
Untreated or uncontrolled hypothyroidism or hyperthyroidism
Drops in blood pressure requiring medication to maintain blood pressure
Any clinically significant out of range laboratory evaluations
Known sensitivity to the study medication or its components
Suicide ideation or type 4 or type 5 on the Columbia suicide severity rating scale
Finding of malignant melanoma on full body skin exam
Impulse disorder conditions
Clareo Health | Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing Off
